Roy’s Roadmap Leads to the Vatican

Krishnendu Roy scanned the room, taking note of the people all around him in the Vatican, and thought, “what the heck am I doing here?”

There was Bill Frist, former majority leader of the U.S. Senate, and there was Tommy Thompson, former governor of Wisconsin and U.S. Secretary of Health and Human Services. There was billionaire philanthropists/businessmen Sean Parker and Denny Sanford, and Ron DePinho, President of MD Anderson Cancer Center, and Carl June, the pioneer of cancer immnotherapy, and there were the heads of the food and drug administrations (FDA) from Europe. And this being the Vatican, there was Cardinal Gianfranco Ravasi (Minister of Culture of the Vatican). Surely, Pope Francis was somewhere nearby.

“All in all, a very high-powered meeting,” says Roy, recalling the International Regenerative Medicine Conference at the Vatican in April.

In fact, it was the highest-powered meeting in a string of high-powered meetings for Roy, Robert A. Milton Chair and professor in the Wallace H. Coulter Department of Biomedical Engineering at Georgia Tech and Emory University, whose travel itinerary the last few months has taken him from Rome, to the White House, to the Harvard Business School in Boston for the annual Business of Regenerative Medicine conference, and most recently, back to Washington D.C. as a member of the newly formed Forum on Regenerative Medicine of The National Academies.

Frequent flying has become a bigger part of Roy’s job description now as director of the $23 million Marcus Center for Therapeutic Cell Characterization and Manufacturing (MC3M) in development at Georgia Tech, Director of the Center for Immunoengineering at Georgia Tech, and technical lead for the National Cell Manufacturing Consortium (NCMC).

Lately, he’s probably spending more time in boardrooms and conferences than in the Laboratory for Cellular and Macromolecular Engineering, where his team works on developing new biomaterial-based strategies for immunoengineering and cell therapy biomanufacturing.

“There are only so many hours in a day, and I’ve taken on more administrative roles, so something has to give. What has given is the amount of time I can spend on my own research and my students,” says Roy, a faculty researcher at the Petit Institute for Bioengineering and Bioscience. “Fortunately, I have a really good group keeping up with the work and producing amazing results.”

Which means Roy has time to take his message about cell manufacturing to some of the world’s halls of influence, like the Vatican, where the Pontifical Council for Culture and the Stem for Life Foundation hosted the third annual International Regenerative Medicine Conference.

The council, Roy says, “actively engages in understanding what is happening in the scientific world and how that affects theology. The meeting was fundamentally focused on how to increase access to revolutionary cell therapies that are right now primarily restricted to the privileged. How do you increase access to common people? I think that was the fundamental question the Vatican was interested in – how do you distribute these life-changing, curative therapies to a broad mass of people?”

Accordingly, Roy made a presentation entitled, “Advanced Manufacturing of Cells: Making Cell Therapies Reproducible, Reliable, Cost-Effective, and Accessible (Challenges, Barriers and a Roadmap to Success).”

Roy and Fred Sanfilippo, director of the Emory-Georgia Tech Healthcare Innovation Program, were part of a panel discussion on “Facilitating Cellular Innovation and Distribution,” moderated by physician and CBS medical correspondent Max Gomez.

That was April 30, the last day of a three-day event that featured a lineup of big-shot media moderators, like Gomez, Katie Couric, Sanjay Gupta, and Robin Roberts. They presided over discussions with researchers, clinicians, university presidents and also a group of people that Roy doesn’t often have exposure to.

“There were a lot of patients there, patients who have benefitted from cell therapies by having their cancer cured or another debilitating disease completely cured,” Roy says. “That was very different for me, because I never get that perspective. Clinicians do all the time. But as an engineer, we don’t get that perspective, and that was very touching.”

Before the weekend was finished, Pope Francis addressed the conference attendees emphasizing the need for access of breakthrough medical therapies to all citizens of the world, regardless of their socio-economic status or religion or which country they live in.

Also, U2 guitarist The Edge became the first rock musician to play at the Sistine Chapel, U.S. Vice President Joe Biden flew in from Iraq, and Roy’s wife and daughter met Pope Francis. “Yeah, it was all pretty amazing, not a typical conference,” Roy says.

In mid-June, Roy went to Washington, D.C., for the White House Organ Summit, and the official unveiling of the National Roadmap for Advanced Cell Manufacturing. The 10-year roadmap was developed by the NCMC, the industry-academic-government partnership created by Georgia Tech and the Georgia Research Alliance.

Last week, Roy was in Boston, where he was part of a panel discussion on “National Manufacturing Programs” (moderated by Petit Institute Executive Director Bob Guldberg) at the annual Business of Regenerative Medicine conference.

The bottom-line theme to Roy’s message these days as a spokesman for and leader in the cell manufacturing movement is this: The aspirin you buy at one drugstore is the same as you might buy from another, but cell-based therapies are a different story: they can vary from one center to another based on how the cells are isolated and processed (i.e., manufactured). There are established ways to quickly assess the efficacy and safety of small-molecule drugs like aspirin, and Roy and his fellow researchers want to develop and establish similar processes for therapeutic cell manufacturing.

“I think, at the end of the day, what matters is getting these high quality products to the people who need them most, at an affordable cost,” Roy says. “That’s the motivation of the Marcus Center, that’s the mission, that’s what I’m passionate about.”